upREACH Perinatal Home Visitation Program

Sponsor
Baylor College of Medicine (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06133829
Collaborator
Texas Department of Family Protective Services (Other)
400
1
2
25
16

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the effectiveness of a new brief home visitation program delivered by non-nurse home visitors to 1) improve connections to community resources based on reported and assessed needs, 2) increase health self-efficacy, and 3) reduce maternal stress compared to a control group that receives standard care from an obstetric clinic.

Secondary administrative data on infant birth outcomes, health care use during the first year of life (appointment adherence), and interaction with government services (such as public assistance or child welfare) will be compared between the groups.

For the intervention group, we will secondarily also assess home visit compliance and satisfaction with the intervention.

Participants will be asked to complete questionnaires that include questions about the participant, their pregnancy, their feelings, their family, and their use of social/community services. Half of the women in this study will be randomly offered free home visitation services and the other half of women in this study will receive standard services from the clinic. The intervention group will be offered at least two free home visits with a non-nurse home visitor. During these visits, the home visitor will provide them with resources and tools to help the participant prepare for their baby. All participants will complete a second round of electronic surveys at approximately 2 months postpartum.

Intervention participant outcomes will be compared to a control group that receive standard care from an obstetric clinic.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: upREACH Home Visitation Program
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
The analyst will be masked to study allocation.
Primary Purpose:
Prevention
Official Title:
upREACH Perinatal Home Visitation Program Randomized Controlled Trial
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Aug 31, 2025
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention Group

Demographic and baseline measures will be obtained from the participants electronically. The participant will receive at least 1 prenatal home visit and at least 1 postpartum home visit. During the visits, the home visitor will review the screening assessments that were completed at baseline, identify health and social needs (including but not limited to referrals to substance use treatment providers, domestic violence hotline/shelters, mental health providers, applications for public assistance, and basic needs provision),work with the client to prioritize their needs, assist with applications and connections to community resources, support the participant in communicating with medical and social service providers, and provide education to help the participant advocate for their health, think ahead for after delivery (prenatal), and understand infant health and safety. At 2 months postpartum, both intervention and control groups will receive a post- survey through REDCap.

Behavioral: upREACH Home Visitation Program
upREACH is a brief perinatal home visitation program delivered by community health workers or similarly qualified personnel. The mission statement of the program is: Families are prepared to bring home their newborn to a safe, stable, and nurturing environment, and have access to tools, resources, and knowledge that promote family health and well-being. Through the program, families will receive a minimum of 2 home visits during pregnancy and/or postpartum from a home visitor (community health worker (CHW) or similarly qualified personnel). The home visitor will assess each family's strengths and needs so they may provide tailored support and brief education to promote maternal health and self-care, infant health and safety, and connection to and knowledge of resources (community orientation).

No Intervention: Control Group

Demographic and baseline measures will be obtained from the participants electronically through REDCap surveys. The participants will receive standard care from the obstetric clinic. At approximately 2 months postpartum, both intervention and control groups will receive a post- survey through REDCap.

Outcome Measures

Primary Outcome Measures

  1. Linkages to Community Resources [through study completion, an average of 5 months]

    Measured by Family Resource Scale (higher score shows that resources are more adequate)

  2. Health Self-Efficacy [through study completion, an average of 5 months]

    Measured by Self-Rated Abilities for Health Practices Scale (higher scores indicate higher health self-efficacy)

  3. Maternal Stress [through study completion, an average of 5 months]

    Perceived Stress Scale (higher scores indicate higher levels of stress)

Secondary Outcome Measures

  1. Trust in Institutions [through study completion, an average of 5 months]

    Measured by Trust in Institutions Instrument (higher scores indicate higher trust)

  2. Appointment Adherence [up to one year postpartum]

    Medical Chart Review of number of appointments attended with Obstetric and Gynecological (OB/GYN) and Pediatric Providers and Self-Report by the participant number of appointments with OB/GYN and Pediatric Appointments

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Pregnant or postpartum women within 3 weeks postpartum (at enrollment)

  • Receiving prenatal or postpartum care from Harris Health Clinic obstetric clinics

  • Speak and read English or Spanish language.

Exclusion Criteria:
  • Unable to speak or read English or Spanish language

  • Women that do not receive perinatal or postpartum care at Harris Health obstetric clinics

  • Women that are not pregnant or greater than 4 weeks postpartum (at enrollment)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Harris Health/Baylor College of Medicine Houston Texas United States 77047

Sponsors and Collaborators

  • Baylor College of Medicine
  • Texas Department of Family Protective Services

Investigators

  • Principal Investigator: Cary M Cain, PhD, Baylor College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cary Cain, Assistant Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT06133829
Other Study ID Numbers:
  • H-53998
  • 62823-S1
First Posted:
Nov 18, 2023
Last Update Posted:
Nov 18, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 18, 2023